RU2775438C1 - Apparatus for intraocular gas injection - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to manual apparatus for delivering therapeutic gas to the patient. The apparatus comprises: a syringe body with an outlet branch pipe; a piston configured to slide in the syringe body and, together with the syringe body, defining a first chamber inside the syringe body; a second chamber located in at least one of the syringe body and the piston. The second chamber therein comprises: an internal volume containing at least a first fluid at a concentration different from the concentration in the atmospheric air and under a pressure exceeding the pressure of the ambient atmospheric air, a hole at the first end of the second chamber; and a valve mechanism located adjacent to the first end, wherein the valve mechanism is configured to seal the hole; a channel and a gap between the second chamber and the first chamber; an activation system functionally connected with the second chamber, wherein the activation system is configured to ensure the release of the first fluid from the second chamber into the first chamber through the channel; an adjustable volume limiter configured to limit the movement of the piston between several user-selected positions corresponding to the several volumes of the first chamber; a filter with a first end connected with the outlet branch pipe of the syringe body, a second end with a filter hole, and a filtering element located between the first end and the second end; and a flow limiter connected with filter hole, with a limiter hole smaller than the filter hole, configured to limit the flow of fluid from the first chamber through the filter hole so that the first fluid from the second chamber is moved from the second chamber through the valve mechanism located adjacent to the first end of the second chamber, through the first chamber, through the first end of the filter, through the filter, through the second end of the filter with the filter hole, and then through the flow limiter hole to the outside from the assembled manual apparatus for gas injection. The flow limiter is therein configured to create a counterpressure against the flow of the fluid from the first chamber, expanding the first chamber to the desired volume corresponding to the user-selected position of the volume limiter.

EFFECT: ensured delivery of theurapetic gas to the patient.

20 cl, 35 dwg

Description

FIELD OF TECHNOLOGY

[0001] The inventions disclosed herein generally relate to devices and methods for introducing gases into the eye of an animal.

BACKGROUND OF THE INVENTION

[0002] Surgical procedures may require the introduction of gases or other fluids into the target area to treat certain injuries, disorders and diseases. In the treatment of eye diseases such as macular holes, retinal tears and detachments, part of the surgical procedure may involve the introduction of gases or other fluids into the eye.

[0003] For example, retinal detachment is an eye disease involving separation of the retina from the retinal pigment epithelium (RPE), the tissue that holds the retina in place. Retinal detachment can occur due to retinal tear, retinal tension, or inflammation that allows fluid to accumulate in the subretinal space, causing the retina to begin to separate from the supporting RPE tissue. This disease can also occur due to posterior vitreous detachment (PVD), proliferative diabetic retinopathy (PDR), trauma, or neovascularization of fibrous or vascular tissue causing retinal detachment from RPE. This condition, if not treated immediately, can lead to partial loss of vision and potentially even blindness.

[0004] Treatment approaches for uncomplicated retinal detachment may include non-surgical methods such as pneumatic retinopexy, laser photocoagulation, or cryopexy. More complex retinal detachments require surgery. Due to the risk of infection, which can potentially cause blindness, such surgeries are performed under sterile conditions to greatly reduce the chance of infection. Surgical methods include vitrectomy, i.e. removal of the vitreous body; dissection and removal of membranes in traction retinal detachment; photocoagulation or cryopexy in case of additional retinal breaks. Following such a surgical procedure, intraocular gas tamponade may be used to keep the retinal tissue in contact with the RPE, allowing the retina to remain attached during the healing process following the surgical procedure.

[0005] Because the intraocular pressure must be kept relatively constant during the healing process, a gas that expands at constant pressure (isobaric process) is typically chosen. Thus, intraocular gas tamponade can be a gas bubble of air mixed with an expanding gas such as sulfur hexafluoride (SF ₆ ), hexafluoroethane (C ₂ F ₆ ) or octafluoropropane (C ₃ F ₈ ). Intraocular gas tamponade dissolves over time depending on the gas used and the concentration. For example, sulfur hexafluoride dissolves in 1-2 weeks when mixed with air at a concentration of approximately 20 percent, hexafluoroethane dissolves in approximately 4-5 weeks when mixed with air at a concentration of approximately 16 percent, and octafluoropropane dissolves in approximately 6-8 weeks when mixed with air at a concentration of approximately 12%. Changing the concentration of these gases affects the duration.

[0006] Current practice involves the use of gases contained in separate pressurized multi-dose containers, which are then transferred to a syringe to be mixed with air and injected into the patient's eye. Therefore, several non-sterile and sterile steps are required during the surgical procedure to fill the syringe with the required concentration of gas and air. These non-sterile and sterile steps are usually performed by a non-sterile operating room nurse and a sterile operating room nurse supporting the surgeon in the sterile field. During the first non-sterile step, the nurse on duty prepares a non-sterile reusable gas container by setting the pressure regulator connected to the gas container to the correct pressure. At the second stage, the operating nurse prepares a sterile syringe by successively connecting a stopcock, a filter and a tube to the syringe. In the third step, the tube is connected to the gas container. The operating room nurse carefully passes the free end of the sterile tubing through an invisible sterile barrier to the waiting non-sterile nurse on duty. The non-sterile nurse on duty receives the tube and is careful to ensure that he/she does not contaminate the operating room nurse or any other sterile surfaces; and connects the tube to the regulator on the gas container. In the fourth step, the syringe is filled with gas from the container. The operating room nurse and nurse on duty coordinate the opening of the pressurized container valve to release gas into the syringe through the connected tubing, filter, and stopcock. The pressure of the released gas is sufficient to push the syringe plunger along the length of the syringe barrel and thus fill the syringe with gas. The operating room nurse ensures that the gas does not push the plunger out of the open end of the syringe barrel and signals the nurse on duty to close the gas bottle valve when the syringe approaches a full state. Then, during the fifth step, all air and gas is removed from the syringe, in order to ensure that a significant portion of the air that may have been present inside the syringe, stopcock, filter, and tubing prior to filling with gas has been removed. The operating nurse turns the stopcock so that the air and gas from the syringe are released into the atmosphere, presses the plunger of the syringe and empties the syringe of all its contents. The operating nurse then turns the stopcock in the opposite direction, returning the connecting channel to the tube and gas container.

[0007] The fourth and fifth steps are repeated several times to further reduce the amount of air that was originally in the syringe, stopcock, filter, and tubing; this blows out most of the air from the syringe, stopcock, filter and tubing and purifies the air system. In the sixth step, the syringe is refilled with gas from the container. The operating nurse disconnects the tubing from the filter and signals the nurse on duty to carefully pick up the tubing and remove it from the sterile field. During the seventh stage, the operating nurse does not expel the entire contents of the syringe, stopping the plunger so that only a measured volume of gas remains in the syringe. For example, the gas can be expelled so that only 12 ml remains inside the syringe. In the eighth step, the operating room nurse replaces the used filter with a new sterile filter and draws the filtered room air into the syringe until the total volume of air-gas mixture in the syringe reaches the correct volume for the required gas concentration.

[0008] For example, atmospheric air can be drawn into the syringe so that the total volume of air and gas is 60 ml, thus reaching a concentration of 20 percent. Since the pressurized containers are non-sterile and the syringe and surgical area are sterile, the above steps must be performed by at least one party in the non-sterile field (usually the nurse on duty), a second party in the sterile field (usually the operating room nurse) and requires coordination and interactions between the two parties.

[0009] The procedure requires a complex set of steps that can increase the likelihood of errors. An error in one of these steps can result in an incorrect concentration of gas being used, which can result in either increased pressure or a shortened duration of retinal tamponade, potentially causing ischemia or failure of the replantation operation, which can lead to blindness. In addition to this, the current practice leads to significant losses of gas, which is both costly and harmful to the environment. Thus, the handling of such gases, especially in pressurized containers containing more than one dose, may present a potential hazard to the operator if mishandled. Thus, some countries may even prohibit the storage of these pressurized cylinders in the operating room.

[0010] Although there have been some approaches to improve the current procedure, such as US Pat. gas filling and venting, these approaches have not been sufficient to address all potential problems. Another approach is disclosed in US Pat. No. 8,986,242, in which the syringe device comprises an internal pressurized balloon with expanding gas in a volume limiting mechanism. In use, the volume limiting mechanism is set to a volume of expanding gas corresponding to the final desired concentration of the gas pack, which may contain expanding gas and air. The expanding gas is vented into the syringe chamber until the syringe plunger contacts the volume limiting mechanism structures and the remaining expanding gas is vented to the atmosphere. A filter is then attached to the outlet of the syringe mechanism and atmospheric air is drawn into the syringe chamber through the filter to create a mixture of expanding gas and air at the required concentration for subsequent administration.

SUMMARY OF THE INVENTION

[0011] An aspect of at least one of the inventions disclosed herein includes the realization that the intraocular gassing device can be assembled and packaged in a manner that reduces or eliminates manipulation required from the user and can further reduce potential sources of contamination. For example, as noted above with respect to the use of the devices disclosed in US Pat. No. 8,986,242, an expanding gas is introduced into the internal mixing chamber of the syringe device, with some excess of the expanding gas vented through the outlet of the syringe. After that, a filter is attached to the syringe outlet, and atmospheric air is drawn into the mixing chamber through the filter.

[0012] An aspect of at least one of the inventions disclosed herein includes the realization that an intraocular gas delivery device may comprise a syringe body, a source of therapeutic gas, and a filter pre-attached to the syringe outlet, for example, prior to venting excess therapeutic gas through outlet pipe. In some embodiments, the gas injection device, with a filter pre-attached thereto, may be packaged in a sterile container for use in a surgical procedure. Thus, the user can open the sterile container, remove the intraocular gas device and use it with the filter in place throughout the gas mixing process. For example, with a filter pre-attached, the user can supply expansion gas to the mixing chamber of a syringe, at least partially filling the mixing chamber with expansion gas or another gas of choice, and in some modes of use, allow excess expansion gas to be expelled from the mixing chamber through the outlet of the syringe body. and then through the filter to the atmosphere. During such release of excess expanding gas, filtration of the expanding gas would not produce any known significant direct beneficial effects. However, using the intraocular gas device in this mode with the filter in place while venting excess expanding gas reduces the risk of contaminating various volumes of space within the device, including between the syringe plunger and the filter membrane of the filter device. In addition, after exhausting the excess expanding gas is completed, the user can then draw atmospheric air into the mixing chamber through the filter without opening the intermediate volumes of space to the atmosphere. Thus, the intermediate volumes of space between the filter membrane and the syringe plunger remain closed to the atmosphere, receiving only atmospheric air that has been filtered through the filter device.

[0013] After the user draws in the required amount of atmospheric air filtered through the filter device, the filter device can be removed and the desired tool can be attached to the outlet of the syringe. For example, in some embodiments, a user may attach a needle to inject a mixture of expanding gas and atmospheric air into the eye of an animal or patient during treatment of a detached retina. After attaching such a needle, the user can blow the needle with a mixture of expanding gas and atmospheric air in the mixing chamber. Thus, prior to surgical use, no volume of space between the filter membrane and the syringe plunger will be exposed to unfiltered atmospheric air.

[0014] Another aspect of at least one of the inventions disclosed herein includes the realization that filling a variable volume gas mixing apparatus with a fixed amount of source gas may result in insufficient expansion of the variable volume chamber and thus the inability to obtain the desired mixture concentration. gases. Thus, an aspect of at least one of the inventions disclosed herein includes the realization that providing a flow restricting device on a filter outlet that is attached to the outlet of an intraocular gassing device can provide useful and/or additional backpressure that can be useful for better ensuring that the mixing chamber expands to the desired volume of therapeutic gas or therapeutic gas component such as expanding gas.

[0015] Another aspect of at least one of the inventions disclosed herein includes the realization that a flow restrictor attached to the outlet of a downstream filter of an intraocular gas device can create an undesirably strong flow restriction during the retraction process. ambient air or ambient air through a filter after the mixing chamber has been filled with therapy gas. Thus, an aspect of at least one of the inventions disclosed herein includes the realization that the provision of a removable flow restrictor on the filter outlet of an intraocular gas device can provide two beneficial modes of operation; creating the required back pressure during the release of excess therapeutic gas during the filling phase of the mixing chamber, allowing the mixing chamber to fully expand to the required volume to contain the required amount of therapeutic gas, subsequently removing the flow restrictor, while the user can manually expand the mixing chamber and draw in atmospheric air through the filter without the increased difficulties that would be associated with such an operation if the flow restrictor were in place. Thus, an aspect of at least one of the inventions disclosed herein includes an intraocular gas injection device comprising a downstream filter device and a removable flow restrictor at the downstream end of the filter device.

[0016] Another aspect of at least one of the inventions disclosed herein includes the realization that if a filter device is attached to a syringe outlet in an operating room, there is a possibility that foreign materials or contaminants will enter the upstream end of the filter device and thus , their content in the volume located between the filter membrane and the piston. Thus, even if some excess expansion gas is subsequently vented through the filter, such contamination and/or foreign matter may be trapped in the filter membrane and then subsequently blown back into the mixing chamber as atmospheric air is drawn back through the filter. Thus, an aspect of at least one of the inventions disclosed herein includes configurations and methods of operation that reduce the likelihood of contaminants and/or foreign materials entering the volumes of space located between the filter membrane and the piston.

BRIEF DESCRIPTION OF GRAPHICS

[0017] FIG. 1A is a schematic representation of an embodiment of a gas mixing device.

[0018] FIG. 1B shows another embodiment of a gas mixing device.

[0019] FIG. 2A is another embodiment of a gas mixing device shown packaged in a closed container for use in an operating room.

[0020] FIG. 2B is a schematic side view of the gas mixing apparatus shown in the first phase of operation.

[0021] In FIG. 2C shows the gas mixing device shown in the second phase of operation.

[0022] FIG. 2D shows the gas mixing device shown in the third phase of operation.

[0023] FIG. 3 shows the components of the gas mixing device, shown in disassembled form.

[0024] In FIG. 4 is a perspective view of the measurement control system and the activation system of the gas mixing device.

[0025] In FIG. 5A is a perspective view of the dosing dial of the gas mixing device.

[0026] FIG. 5B is a cross-sectional view of the metering control dial of the metering control system shown in FIG. four.

[0027] FIG. 6 is a perspective view of the piston housing of the measurement control system shown in FIG. four.

[0028] In FIG. 7 is a perspective view of the activation system shown in FIG. four.

[0029] FIG. 8A is a sectional view of the measurement control system and activation system shown in FIG. 4, in the first or "closed" position.

[0030] FIG. 8B is a sectional view of the measurement control system and activation system shown in FIG. 4, in the second or "open" position.

[0031] In FIG. 9 is a side view of an embodiment of an activation system, a pressure chamber, and a first pressure control system according to a second embodiment of the gas mixing apparatus.

[0032] FIG. 10 is a sectional view of the activation system, pressure chamber, and first pressure control system shown in FIG. 9, in the first position.

[0033] FIG. 11 is a sectional view of the activation system, pressure chamber, and first pressure control system shown in FIG. 9 in the second position.

[0034] FIG. 12 is a sectional view of the components, including the mixing chamber and the second pressure control system of the gas mixing device.

[0035] FIG. 13 is an enlarged sectional view of the mixing chamber and the second pressure control system shown in FIG. 12.

[0036] FIG. 14 is an enlarged sectional view of the mixing chamber and the second pressure control system shown in FIG. 12, with an additional nozzle.

[0037] FIG. 15A is a perspective view of a dosing dial according to an embodiment of a measurement control system.

[0038] FIG. 15B is a cross-sectional view of a dosing dial according to an embodiment of a metering control system.

[0039] FIG. 16 is a perspective view of a piston housing according to an embodiment of a measurement control system.

[0040] In FIG. 17 is a perspective view of components according to an embodiment of an activation system.

[0041] In FIG. 18 is a sectional view of the measurement control system and the activation system in the first, "initial" or "pre-activation" position, showing the operation of the locking mechanism.

[0042] FIG. 19 is a sectional view of the measurement control system and activation system in the second or "open" position, showing the operation of the locking mechanism.

[0043] FIG. 20 is a sectional view of the measurement control system and activation system in the third or "closed" position, showing the operation of the locking mechanism.

[0044] FIG. 21 is a sectional view of the measurement control system and activation system in the first, "initial" or "pre-activation" position, showing the operation of the latch.

[0045] FIG. 22 is a sectional view of the measurement control system and activation system in the second or "open" position, showing the operation of the latch.

[0046] FIG. 23 is a sectional view of the measurement control system and the activation system in the third or "closed" position, showing the operation of the latch.

[0047] FIG. 24 is an enlarged view of an embodiment of an activation system, a pressure chamber, and a storage element pressure control system.

[0048] FIG. 25A is a sectional view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 24 in the first, "initial" or "pre-activation" position.

[0049] FIG. 25B is an enlarged view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 25A.

[0050] FIG. 26A is a sectional view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 24, in the second or "open" position.

[0051] FIG. 26B is an enlarged view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 26A.

[0052] In FIG. 27A is a sectional view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 24, in the third or "closed" position.

[0053] FIG. 27B is an enlarged view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 27A.

[0054] FIG. 28 is an enlarged view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 25A illustrating an embodiment of a storage element in more detail.

[0055] FIG. 29 is an enlarged view of an embodiment of the activation system, pressure chamber, and pressure control system of the storage element shown in FIG. 26A illustrating an embodiment of a storage element in more detail.

[0056] FIG. 30 is a schematic side view of yet another embodiment of a manual gas injection device assembly, removed from its packaging and prepared for injection of a therapeutic gas or gas component into a mixing chamber, and having a flow restrictor connected downstream of the filter device.

[0057] FIG. 31, the manual gas injection device shown in FIG. 30 is shown exploded.

[0058] FIG. 32 is an enlarged sectional view of the complete inserter shown in FIG. thirty.

[0059] FIG. 33 is an enlarged side view of the flow restrictor in the embodiment shown in FIG. thirty.

[0060] FIG. 34 is an enlarged perspective view of the flow restrictor shown in FIG. thirty.

[0061] In FIG. 35 is an enlarged sectional view of the flow restrictor shown in FIG. thirty.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0062] The following detailed description is for illustrative purposes only and is not intended to limit embodiments of the subject matter or the scope and use of these embodiments. In the context of this document, the word "illustrative" means "serving as an example, exemplar or illustration". Any implementation described herein as given by way of example should not necessarily be construed as preferred or advantageous over other implementations. Furthermore, it is not intended to enter into any theory either directly or indirectly presented in the previous sections such as the field of technology, the background of the invention, the brief description, or the following detailed description.

[0063] Certain terminology may be used in the following description solely for the purpose of reference and, therefore, is not intended to be limiting. For example, terms such as "top", "bottom", "above" and "under" refer to the directions on the graphics referenced. Terms such as "proximal", "distal", "anterior", "dorsal", "posterior", and "lateral" describe the orientation and/or location of the parts of a component in a consistent but arbitrary frame of reference that is clear from the text and relevant graphics describing the component in question. This terminology may include words specifically mentioned above, their derivatives and words of similar meaning. Similarly, the terms "first", "second" and other similar numerical terms refer to structures.

[0064] In the context of this document, the terms "anterior" and "distal" refer to parts of the considered device that are located farther from the user (eg, surgeon) of the device during the insertion operation. As used herein, the terms "posterior" and "proximal" refer to parts of the device that are closer to the user (eg, surgeon) of the device during an insertion operation.

Device for mixing two gases

[0065] FIG. 1A depicts an embodiment of a gas mixing kit 2 which may include a gas mixing device 10 housed in a container 4. The container 4 may be any type of container suitable for use as part of the components of a surgical kit with a sterilized internal environment for use in an operating room, for example in a sterilized operating room field for use during surgery. In some of these containers, the thermoformed plastic tray includes structures to hold the components that contain the surgical components in a predetermined order, and a frangible seal made of a thin membrane-type material. Surgical components, in some embodiments, containing the gas mixing device 10, are sterilized and inserted into the container 4 in a sterilized environment, and in some embodiments, with an inert gas sealed therein. Other types of containers may also be used.

[0066] The gas mixing device 10 may be configured to generate a therapeutic gas or therapeutic gas components. For example, gas mixing device 10 may be configured to receive a therapeutic gas or component of a therapeutic gas and a second gas, which in some embodiments may be atmospheric air, in a mixing chamber for subsequent release for therapeutic use. For example, in some embodiments, gas mixing device 10 can be used to create a therapeutic gas mixture for administration to a patient, and in some embodiments, to a patient's eye.

[0067] Continuing with FIG. 1A, the gas mixing device 10 may include a mixing system 310, a pressure control system 710, and a filter device 760. The mixing system 310 may include an outer housing 311, a therapeutic gas source 410, and a mixing chamber 510. The mixing chamber 510 may be defined by a portion of the housing 311 and a movable wall, such as a plunger 460. The plunger 460 may be in the form of a plunger typically provided in a syringe device.

[0068] The mixing system 310 may also include a pressure control system 610 located between the source 410 and the mixing chamber 510. The pressure control system 610 may include a valve configured to hold the source 410 closed and actuate the release of the contents of the source 410 into mixing chamber 510 through valve 610.

[0069] The pressure control system 710 may be configured to control the flow of gas entering and leaving the mixing chamber 510. For example, pressure control system 710 may be configured to vent excess gas supplied to mixing chamber 510 initially from source 410 to atmosphere. pressure in excess of atmospheric pressure. In addition, the pressure control system 710 may be configured to allow gas to be introduced into the mixing chamber 510 when the pressure within the mixing chamber 510 is below atmospheric pressure.

[0070] The filter device 760 may include a filter membrane (not shown) or other filter device configured to remove particles, foreign materials, or other substances from gases flowing through it. The filter device 760 may include an outlet end 761 that is open to the atmosphere. The outlet 761 may be used to vent gas from the mixing chamber 510 as well as to allow atmospheric air to enter the filter device 760 for mixing in the mixing chamber 510. outlet 761 and/or included in it.

[0071] Kit 2 can be prepared in a sterile environment and contain a gas mixing device 10 with or without an additional flow restrictor 1300 such that the filter element 760 is attached to the mixing device 310 and is sealed within the container 4. In use, the practitioner may open container 4 and release therapeutic gas or gas component from source 410 into mixing chamber 510.

[0072] During the introduction of gas into the mixing chamber 510, the piston 460 will move to the left (as shown in Fig. 1A), thereby expanding the volume of the mixing chamber 510 in accordance with the introduction of therapeutic gas from the source 410 into the mixing chamber 510. For example, in In some embodiments, source 410 is a pressurized container of therapeutic gas or a component thereof. Thus, releasing pressurized gas into mixing chamber 510 will increase the pressure within mixing chamber 510, thereby causing piston 460 to move and thereby increasing the volume of mixing chamber 510.

[0073] Pressure control system 710 may include a valve mechanism configured to open when superatmospheric pressure is applied while providing flow restriction, thereby generating some back pressure sufficient to cause piston 460 to move and allow expansion of the mixing chamber 510. With enough piston movement 460 to allow the mixing chamber 510 to expand to the desired volume of therapeutic gas, the pressure control device system 710 will cause the remaining excess gas from the source 410 to exit through the filter device 760 and outlet 761. As the excess gas flows through the filter device 760, the upstream side of the filter device 760 is not expected to trap any foreign material or contaminants, since all internal spaces within the device 10 must be pre-sterilized and stored in a sterile environment inside the container 4. Thus, during the release of excess gas from the mixing chamber 510, the filter device 760 is unlikely to perform any required filtering functions.

[0074] After chamber 510 has been filled with the desired volume of therapeutic gas or component, piston 460 can be manually moved, for example, to the left (as shown in Fig. 1A) to draw atmospheric air into outlet 761 through filter device 760, through the pressure control system 710 and into the mixing chamber 510. Thus, the filter device 760 can trap foreign material and/or other unwanted gases that may be present in the atmosphere and prevent these substances from entering the mixing chamber 510.

[0075] The piston 460 can be moved to the desired location corresponding to the desired mixture of gases from the source 410 and atmospheric air. Once the desired mixture has been formed in the mixing chamber 510, the user may remove the filter 760 and attach a delivery device (not shown), such as a hypodermic needle, to the pressure control device 710 for further release.

[0076] For example, in the context of using device 10 to mix expanding gas from source 410 with ambient air to treat a detached retina, a user may attach a hypodermic needle to the downstream side of pressure control system 710 in the depicted location of filter device 760. Thus, with the needle attached, the user can manually move the plunger 460 to the right (as shown in FIG. 1A) and purge the hypodermic needle with an uncontaminated gas mixture from the mixing chamber 510, then continue the procedure to provide treatment to the patient, for example, by injecting a bubble of a mixture of expanding gas and atmospheric air from the mixing chamber 510 into the patient's eye.

[0077] In some embodiments, as described above, device 10 may include a flow restrictor 1300. The restrictor 1300 flow may provide additional restriction of the flow leaving the outlet 761 and entering it. Thus, during the addition of therapeutic gas to mixing chamber 510, flow restrictor 1300 can provide additional back pressure and thus ensure that sufficient positive pressure is created in mixing chamber 510 to move piston 460 (to the left) and thus provide full expansion of the mixing chamber 510 to the desired volume, corresponding to the desired final concentration of the mixture in the mixing chamber 510.

[0078] FIG. 1B shows yet another embodiment of the gas mixing kit 2, indicated generally by the reference numeral 2a. The set 2a contains a gas mixing device 10a contained in a container 4a. As described above with reference to container 4, container 4a may contain system 10a in a sterilized state for opening and use in a surgical environment. The gas mixing device 10a may include a measurement control system 110a, an activation system 210a, and a mixing system 310a configured to create a mixture of two or more gases with a desired concentration ratio, and a pre-attached filter 760a. In addition, optional set 2a may include a removable flow restrictor 1300 attached to the outlet 761a of the filter device 760a. The mixing system 310a may also optionally include a pressure chamber 410a and a mixing chamber 510a.

[0079] The mixing system 310a may also include a pressure control system to improve the operation of the mixing system 310a. In some embodiments, mixing system 310a further comprises a first pressure control system 610a and a second pressure control system 710a.

[0080] The measurement control system 110a may be in the form of a metering mechanism contained in the mixing system 310a to control certain aspects of the devices contained therein. In some embodiments, measurement control system 110a may be a user-configurable and adjustable device. The activation system 210a may be operatively connected to the pressure chamber 410a to activate the device and begin mixing the gases in the mixing system 310a.

[0081] The optional pressure chamber 410a may contain at least one of two or more gases to be mixed in the mixing system 310a. In some embodiments, the gas contained in pressurized chamber 410a may be at a pressure higher than at ambient conditions. In addition, pressurized chamber 410a may contain gases at concentrations different from those in the atmosphere. The pressure chamber 410a may be configured to be in fluid communication with the first pressure control system 610a. In other embodiments, pressure chamber 410a may be in direct fluid communication with mixing chamber 510a. The pressure chamber 410a may be configured to be contained within an inserter. The pressure chamber 410a can also be configured to be external to the inserter. The first pressure control system 610a may be configured to maintain a predetermined pressure difference between the pressure chamber 410a and the mixing chamber 510a.

[0082] The mixing chamber 510a may be configured to receive gas from the pressurized chamber 410a, either directly or through the first pressure control system 610a. In some embodiments, the mixing chamber 510a may further be configured to receive the second gas to be mixed from outside the mixing system 310a, such as from an external gas container or the atmosphere. The mixing chamber 510a may be configured to be in fluid communication with the second pressure control system 710a at the outlet of the mixing chamber 510a. In other embodiments, the mixing chamber 510a may be in direct fluid communication with the atmosphere at the outlet of the mixing chamber. Examples of each of these subsystems are described separately below.

[0083] In some embodiments, the measurement control system 110a is configured to control gas concentrations in the gas mixing device 10a. In some embodiments, measurement control system 110a is operatively coupled to mixing system 310a. Preferably, measurement control system 110a is operatively coupled to either pressure chamber 410a or mixing chamber 510a such that measurement control system 110a can modify various aspects of pressure chamber 410a and/or mixing chamber 510a.

[0084] In some embodiments, the measurement control system 110a is capable of controlling characteristics such as, but not limited to, the volume of gas contained in the mixing chamber 510a. Other characteristics such as pressure are also considered to be controlled by the measurement control system 110a. Preferably, the measurement control system 110a is adjustable so that the user can select the desired concentration ratio of the gas that can be expelled from the gas mixing device 10a. This advantageously allows the user to have only one gas mixing device 10a for a wide range of desired concentration ratios. Thus, measurement control system 110a may include user-controlled switches, such as dials, that change the operation of components in mixing system 310a, such as pressure chamber 410a, mixing chamber 510a, first pressure control system 610a, and second pressure control system 710a.

[0085] The pressure chamber 410a may be configured to store one or more gases in the interior of the pressure chamber 410a for a period of time before mixing the two or more gases in the gas mixing device 10a. Conditions within the interior space may differ from atmospheric conditions, and therefore, the interior space should generally reduce the release of such gases from the interior space or reduce the entry of non-stored gases into the interior space before mixing of the two or more gases occurs.

[0086] In some embodiments, one or more gases in the interior are at a higher pressure than ambient atmospheric conditions. In addition, one or more of the gases may also be gases with concentrations different from those in ambient atmospheric conditions. In some embodiments, the implementation of the interior space may be divided into separate sub-sections or parts to contain one or more gases. In this way, different pressures and/or different concentrations of gases can be maintained in these separate parts of the internal space.

[0087] In some embodiments, the implementation of gases can be additionally placed in various structural elements of the internal space. Such structural elements can be used to more effectively reduce the release of stored gases and/or reduce the entry of non-stored gases. In some embodiments, the gases stored in pressure chamber 410a are preloaded from the time of manufacture. In other embodiments, it is contemplated that the contents of the pressurized chamber 410a can be loaded by the user of the gas mixing device 10a. For example, stored gases may be contained in a cartridge-type removable device, which may advantageously facilitate the replacement of such gases.

[0088] In some embodiments, the activation system 210a is configured to activate the operation of the gas mixing device 10a and start the process of mixing two or more gases in the mixing system 310a. Thus, the activation system 210a is operatively connected to the mixing system 310a and can be connected to both the mixing chamber 310a and the pressure chamber 410a. The activation system may cause the pressure chamber 410a to be activated and the gases contained therein to be released into the mixing chamber 510a. In some preferred embodiments, the activation system 210a can cause the pressure within the pressure chamber 410a to rise such that the first pressure control system 610a is activated, thereby allowing fluid to flow from the pressure chamber 410a into the mixing chamber 510a. Activation system 210a may include a device configured to activate a portion of pressure chamber 410a that contains gas at a higher pressure than the remainder of pressure chamber 410a, thereby increasing the pressure within the particular section of pressure chamber 410a. In a preferred embodiment, activation system 210a may open a seal in mixing chamber 510a to release pressurized gas and thereby depressurize the entire pressurized chamber 410a. In such embodiments, the activation system 210a may include a piercing device capable of piercing the seal. Other devices and methods may also be used. The use of an activation system 210a provides advantages by allowing the gas mixing device 10a to potentially be pre-filled prior to use and safely stored.

[0089] The activation system 210a can also be operatively connected to the mixing chamber 510a, allowing the user to manually change certain aspects of the device. In some embodiments, activation system 210a may be used to change the volume of mixing chamber 510a. The activation system 510a can also be used to change the pressure in the mixing chamber 510a.

[0090] In some embodiments, the first pressure control system 610a is configured to function as a separation mechanism between the pressure chamber 410a and the mixing chamber 610a. The first pressure control system 610a may be activated when a predetermined pressure difference between the pressure chamber 410a and the mixing chamber 510a is reached. In some preferred embodiments, the first pressure control system 610a may be comprised of at least one valve assembly. The valve assembly may open when the pressure inside the pressure chamber portion 410a is higher than the pressure in the mixing chamber 510a. The valve assembly can be a check valve, flapper valve, non-return valve, or one-way valve. Such valves may also include ball check valves, diaphragm check valves, swing check valves, check valves, lift check valves, inline check valves, and duck nose valves. Other pressure control mechanisms may also be used. It is further contemplated that the first pressure control system 610a may also be activated by means other than pressure differences in system 610a.

[0091] In some embodiments, the mixing chamber 510a is configured to provide the function of a space in which two or more gases can be mixed to obtain a desired ratio of gas concentrations. The mixing chamber 510a may have a variable volume controlled by using an activation mechanism. The mixing chamber 510a can receive mixing gases exclusively from the pressure chamber or from gases already present in the mixing chamber 510a. Mixing chamber 510a can also receive gases from secondary sources. In some embodiments, the mixing chamber 510a may receive air from the atmosphere to mix with gases coming from the pressurized chamber 310a and/or gases already present in the mixing chamber 510a.

[0092] In some embodiments, the second pressure control system 710a is configured to act as a separation mechanism between the mixing chamber 510a and the surrounding atmosphere. The second pressure control system 710a can be activated when a predetermined pressure difference between the mixing chamber 510a and the surrounding atmosphere is reached. In some preferred embodiments, the second pressure control system 710a may be comprised of at least one valve assembly. The valve assembly may open when the pressure in the mixing chamber 510a is higher than the pressure in the surrounding atmosphere. The valve assembly can be a check valve, flapper valve, non-return valve, or one-way valve. Such valves may also include ball check valves, diaphragm check valves, swing check valves, check valves, lift check valves, inline check valves, and duck nose valves. Other pressure control mechanisms may also be used. It is further contemplated that the second pressure control system 710a may also be activated by means other than pressure differences in system 710a.

[0093] Set 2a may also include a filter device 760a attached to the outlet of the mixing chamber 510a and/or the outlet of the second pressure control system 710a. The filter device 760a may include an outer housing and an inner filter component, such as a membrane with the desired porosity or aperture size, to filter unwanted foreign particles, substances, and/or gases. The filter device 760a may include an outlet 761a that is open to the atmosphere. During assembly of the kit 2a, the components 110a, 210a, 310a, 410a, 510a, 610a, 710a and the filter device 760a are attached to the mixing device 10a in the sterile packaging room and sealed into the container 4a in a sterilized state and optionally filled with a sterilized inert gas . Thus, all empty interior spaces within and between components 110a, 210a, 310a, 410a, 610a, 510a, 710a, and 760a will be sterilized and/or filled with inert gas within sealed package 410a. Optionally, as noted above, the set 210a may also include an additional flow restrictor 1300 attached to the outlet 761a of the filter device 760a.

Job Overview

[0094] FIG. 2A-2D illustrate the operation of an embodiment of a gas mixing device 10b. As shown in FIG. 2A, the device 10b may be in the initial phase with the activation system 210b in the first or "closed" position and contained in the package 4b. In this phase, the device 10b is in a fully sterilized state, with all internal volumes, including those between the filter element of the filter device 760 and the piston 460 (not shown), sterilized and/or filled with a sterilized inert gas.

[0095] The practitioner or other user may remove the device 10b from the package 4b and use the measurement control system 110b to select the desired concentration of therapeutic gas to mix. The user can then use the activation system 210b to release gas from the gas source 410b into the mixing chamber 510b.

[0096] For example, as shown in FIG. 2B, the gas contained in pressurized chamber 410b may be released, and in embodiments comprising a first pressure control system, the first pressure control system may open in response to a change in pressure within the chamber. Thus, fluid can flow from the pressure chamber into the mixing chamber 510b, thereby causing the volume of the mixing chamber 510b to expand. However, due to the components of the measurement control system 110b, the piston 460b of the mixing chamber 510b stops at a user-selected first volume and cannot expand beyond that first volume. This first volume can be set based on the desired concentration of the injected volume. During this first phase of operation, excess gas can also be removed from the mixing chamber 510b via the second pressure control system 710b. As soon as the mixing chamber reaches this first volume, the first phase of operation ends and the second phase of operation begins.

[0097] During the second phase of operation, the mixing chamber 510b may remain in the first volume while the pressure inside the mixing chamber 510b is vented from the system through the filter 760 and the second pressure control system 710b. By overflowing mixing chamber 510b with the desired gas and then venting that gas, it is ensured that any atmospheric or inert gas introduced into the container during packaging in mixing chamber 510b that might be contained in mixing chamber 510b prior to activation is substantially removed. from the mixing chamber 510b and displaced by the gas originally contained in the pressure chamber. Once the pressure in the mixing chamber 510b reaches the set value based on the configuration of the second pressure control system 710b, the release of gas from the mixing chamber 510b is stopped and the second phase of operation is completed.

[0098] During the third phase of operation, as shown in FIG. 2C, after sufficient time has elapsed for the gas to reach ambient pressure, the user may then set the activation system 210b to the first or "closed" position, thereby unlocking the measurement control system 110b. The user can then manually increase the volume of the mixing chamber 510b to the injectable volume. When the user manually increases the volume of the mixing chamber 510, ambient air is drawn from the atmosphere through the filter device 760b into the mixing chamber 510b. Thus, the filter 760b can filter foreign particles or gases from the ambient air before the air enters the chamber 510b.

[0099] After completion of the third phase, as shown in FIG. 2D, filter device 760b may be removed and an additional device configured to deliver therapeutic gas to mixing chamber 510b (not shown) may be attached. For example, a hypodermic needle may be attached to device 10b to support therapeutic delivery of therapeutic gas in mixing chamber 510b to a patient. In some embodiments, the gas in mixing chamber 510b may be a mixture of expanding gas and filtered atmospheric air to treat a detached retina. In such a scenario, the hypodermic needle attached to the device can be purged of any gas that may be present therein by depressing piston 460b to release some of the gas from mixing chamber 510b through the hypodermic needle. Thereafter, a needle may be inserted into the patient's eye and the gas from mixing chamber 510b may be used to create one or more gas bubbles in the patient's eye to treat retinal detachment. Other use cases are also possible.

[0100] In other embodiments, fewer or more work phases may be performed. In some embodiments, only one phase of operation may be performed. For example, pressurized chamber 410a may contain a gas at a predetermined concentration level. During one phase of operation, the user may activate device 10b such that gas or fluid flows from pressurized chamber 410a into a second chamber, such as mixing chamber 510a, until the chamber reaches a predetermined volume. The gas or fluid can also be expelled or removed by the pressure control system until the desired pressure is reached inside the chamber. After the release of gas, the device 10b can be ready for use. As will be apparent to one of skill in the art, little or no mixing may actually be performed in such an embodiment.

System overview

[0101] In FIG. 3 shows the components of an embodiment of a gas mixing apparatus 10b, which include a measurement control system 110b, an activation system 210b, a pressure chamber 410b, a mixing chamber 510b, a first pressure control system 610b, and a second pressure control system 710b. The metering control system 110b may include a metering dial 120 and a piston housing 160 that can be inserted into the metering dial 120. The activation system 210b may include an actuator rod 220 and an activation switch 260. The activation system 210b may be operatively connected to the measurement control device 110b to control the operation of the gas mixing device 10b. System 210b activation can be inserted into the body 160 of the piston.

[0102] The pressure chamber 410b may be comprised of a housing 420, a gas-containing cylinder 436, a release mechanism 444 for venting the gas contained in the cylinder 436, a filter 448 to reduce the amount of non-gaseous or bacterial material flowing from the housing 420, and a piston seal 460 . The mixing chamber 510b may be comprised of a syringe body 520. The first pressure control system 610b may include a valve body and associated valve components. The second pressure control system 710b may also include associated valve components.

Measurement control system and activation system

[0103] In FIG. 4 shows an embodiment of a combined measurement control system 110b and an activation system 210b. The measurement control system 110b may include a dosing dial 120 and a piston housing 160. The activation system may include an actuator rod 220 (shown in FIG. 7) and an activation switch 260.

[0104] In FIG. 5A and 5B show an embodiment of a dial control 120 of the gas mixing device 10b that allows the user of the device 10b to selectively change the concentration of the injected volume. The dial gauge 120 is comprised of two structural components, a dial gauge housing 122 and a dial gauge cap 124, which can be coupled to the dial gauge housing 122 to allow the dial gauge 120 to be detachably attached to another component of device 10b. This may advantageously facilitate assembly of the device and, in some reusable embodiments, may facilitate disassembly for re-sterilization. In some embodiments, the dial cap 124 may be detachably attached to the dial dial housing 122 using fasteners such as screws, rivets, clips, and other fastening mechanisms known in the art. By attaching the dial cap 124 to the dial dial housing 122, an annular slot 126 and an annular shoulder 128 can be formed so that the dial dial 120 can be attached to another component of the device 10b. For example, the annular slot 126 and the annular shoulder 128 may correspond to the flange 526 located on the body 520 of the syringe.

[0105] The dial gauge housing 122 may have a generally cylindrical member 130 with a flange 132 at its upper end and a channel 134 substantially centrally located on the cylindrical member 130 and extending through the entire dial gauge housing 122. Since the dial gauge housing 122 is configured to control the gas concentration in the injected volume, the dial gauge housing 122 may include dosage indicators 136 on a surface visible to the user of the fully assembled device 10b. In the illustrated embodiment, dosage indicators 136 are located on the top surface of flange 132, although any location that can be seen by the user may be used. Dosing indicators 136 may provide the user of the device with information regarding the operation of the device 10b. In the illustrated embodiment, dosing indicators 136 show a range of numbers: 18, 19, 20, 21, and 22, corresponding to the concentrations of sulfur hexafluoride (SF ₆ ) that will be generated in the injection volume if device 10b is activated. As will be apparent to those skilled in the art, the ranges used may depend on the gas used and the application of the gas. In addition, in some embodiments, this range may be further subdivided to provide improved control of the desired concentration.

[0106] The dial gauge body 122 may have slots 138, slot 138, and adjustable stops 142 corresponding to the gauges 136. In the illustrated embodiment, dial gauge housing 122 has five distinct slots 138 along the inner surface of channel 134 that correspond to the five integer values above. In other embodiments, the dial gauge housing 122 may have fewer or more slots than the number of values provided by the dosage gauges 136.

[0107] Each of these slots 138 is associated with adjustable stops 142 that extend inward from the slots 138. As illustrated above, these adjustable stops 142 may take the form of surfaces extending from the top surface of the flange 132 having bottom end surfaces 142a spaced at predetermined distances. from the bottom end of the tubular body 130. In some embodiments, the adjustable stops 142 do not have to protrude from the top surface, but instead are small protrusions with the bottom end surfaces 142a spaced at predetermined distances towards the bottom end of the cylindrical member 130. These adjustable stops stops 142 are configured to interact with components contained in piston housing 160, such as latch 228, or with piston housing 160 itself, to control the expansion volume of mixing chamber 510b during the first and second phases of operation, limiting rearward extension of piston housing 160 during uh quiet phases (see fig. 2B). Thus, adjustable stops 142 travel different distances depending on the concentration to which stop 142 corresponds. For example, a concentration of 21 percent travels down a shorter distance than a concentration of 20 percent, thereby allowing mixing chamber 510b to hold more of the first gas. End of the third phase of operation (FIG. 2C) before adding filtered ambient air during the fourth phase (FIG. 2D). Thus, when a concentration of 21 percent is selected, the piston housing 160 can be allowed to move back a greater distance, thereby allowing greater expansion of the mixing chamber 510b during the first phase of operation. Therefore, as should be obvious, adjustable stops 142 are used to control the first expansion volume of the first phase of operation.

[0108] On both sides of the slots 138 there are slots 138 that extend inwardly from the inner surface of the channel 134. In some embodiments, the slot 138 extends inwardly from the inner surface of the channel 134 a greater distance than the adjustable stops 142. The slot 138 may be configured to preventing device 10b from switching to a different concentration value after device 10b has been activated. This can be especially important in applications where a specific gas concentration may be required and any slight change to this value can have significant adverse effects. In the illustrated embodiment, the slot 138 is configured to significantly reduce the likelihood that the piston housing 160 will rotate to another adjustable stop 142 during at least the first two phases of operation. In some embodiments, these guides may be removed if a constantly adjustable dispenser is required. In such an embodiment, the adjustable stop 142 may instead be in the form of an incline rather than having multiple steps.

[0109] The ratchet pawl 122 may further comprise a ratchet pawl 144 on the inner surface of the channel 134 that extends inward toward the center of the channel 134. The ratchet pawl 144 may be articulated and configured such that the ratchet pawl 144 can be deformed to movement and provide resistance during deformation. This ratchet pawl 144 may correspond to features located on the plunger body 160 to facilitate proper orientation with respect to the selected concentration. Such a mechanism may further provide tactile feedback to the user of the device indicating that proper alignment has been achieved. This tactile feedback can advantageously reduce the likelihood of activation in the wrong orientation. Feedback mechanisms and other types of matching mechanisms may also be used.

[0110] In FIG. 6 shows an embodiment of a piston body 160 which comprises a tubular frame 162 as a whole, a handle 164 at one end of the piston body 160, a switch ring 166 located therebetween, and a passage 168 centrally located in the tubular frame 162 and extending the entire length of the body 160. piston. The tubular frame 162 is made with the possibility of displacement with sliding and partial rotation with sliding in the channel 134 of the dial regulator 120 dosing.

[0111] The tubular frame 162 has a retaining mechanism 170 in the form of a clip that is hinged to the tubular frame 162. The retaining mechanism 170 may be configured to hold a component such as the housing 420 of the pressure chamber 410b. The holding mechanism 170 advantageously allows the component to be attached without the use of tools, thereby facilitating the assembly process of the entire device. In addition, the retaining mechanism 170 can also be configured such that the component can be removed from the tubular frame 162, allowing the device 10b to be reused, or in other embodiments that allow the device 10b to be reused, to facilitate the re-sterilization process if such process is used for the device. Other types of retaining mechanisms may also be used in place of the clips shown in the illustrated embodiment and may include fasteners such as screws.

[0112] The tubular frame 162 may further include a guide 172 that protrudes outward from the outer surface of the tubular frame 162. The guide 172 may extend from the lower end of the tubular frame 162 for a certain distance to the upper end of the tubular frame 162. The guide 172 is configured to be placed in the grooves 138 and a groove 138 located along the inner surface of the channel 134 of the housing 122 of the dial dosing regulator. Thus, the guide 172, when positioned between the slots 138, can prevent the piston housing 160 from rotating. This can advantageously prevent the plunger body 160 from moving to another adjustable stop 142 after the start of the first phase of operation and thus reduce the risk of incorrect concentration in the injected volume. The guide 172 is preferably sized such that when the piston body 160 is fully inserted, the guide 172 is only slightly below the groove 138 so that the piston body 160 is free to rotate to various concentrations during the initial phase of operation (see FIG. 2A). However, since the guide 172 is only slightly below the slot 138, when extended a short distance, the guide 172 may lock into the selected rail 140. This arrangement allows the guide 172 to be locked shortly after the device 10b is activated. In addition, the guide 172 preferably protrudes outwardly from the tubular frame 162 only a sufficient distance so that it can contact the slot 138, but not so much that it touches the adjustable stops 142 located between the slots 138. Thus, this may allow the adjustable stops 142 do not interfere with guide 172 during operation.

[0113] The roll cage 162 may further comprise a latch opening 174 to allow the latch 228 (FIG. 7) located on the activation rod 220 to protrude outwardly from the roll cage 162. The latch opening 174 is preferably centrally located just above the topmost portion of the rail. 172. As will be detailed below, in the first or "closed" position, the latch 228 is retracted so that it does not protrude beyond the guide 172 and thus does not contact the adjustable stop 142 (see FIG. 8A). While in the second position, the latch 228 extends outward from the roll cage 162 behind the guide 172 so that the latch 228 can contact adjustable stops 140, such as bottom surfaces 142a, thereby preventing further extension of the piston housing 160 while the latch is in the second position. (see Fig. 8B). Thus, the volume to which chamber 510b can expand is limited by latch 228 and surface 142a. In some embodiments, the latch opening 174 may be positioned such that if the piston housing 160 is not properly oriented within the dial gauge 120 during the initial phase of operation (shown in FIG. 2A), the latch 228 can be prevented from protruding out into the second or " open" position using the rail 140 of the dial regulator 120 dosing. This can advantageously prevent device 10b from being activated in the wrong orientation.

[0114] The tubular frame 162 may further comprise ratchet slots 176 in the form of cutouts along its outer surface. The ratchet slots 176 are configured to receive the ratchet pawl 144 of the dial gauge housing 122, which provides a mechanism to maintain proper orientation of the piston housing 160 within the dial gauge housing 122, providing resistance to rotation when the pawl 144 enters one of the ratchet slots 176 . In addition, advantageously at every point where the ratchet pawl 144 engages the ratchet slots 176, the user of the device 10b can also receive tactile feedback when the plunger body 160 is properly oriented within the dial gauge body 120.

[0115] Continuing with FIG. 6, the ring 166 may include an annular protrusion extending from the outer surface of the tubular frame 162. The switch ring 166 may further include a switch indicator 178, which may be in the form of a small protrusion located on the switch ring 166. The switch pointer 178 may correspond to and be aligned with the dosage indicators 136 located on the dosage dial housing 122 (FIG. 5A) to indicate the concentration level that will be obtained when the piston housing 160 is oriented in a position that corresponds to the alignment of the latch 228 with corresponding surface 142a. Such a system may advantageously provide the user of the device with easily viewable information about the selected concentration level. The switch pointer 178 may advantageously be colored to facilitate the use of the device 10b.

[0116] The handle 164 may extend in a radial direction relative to the longitudinal axis of the tubular frame 162. The handle 164 may be shaped so that the user of the device 10b can grasp the handle 164 firmly and use the handle to either further push the piston housing 160 back and out of the device 10b, or to further press the piston housing 160 forward into the device 10b. The handle 164 may further comprise an opening 180 for receiving a coupling mechanism for the activation switch 260 . Thus, the activation switch 260 can rotate around the coupling mechanism to operate the actuator rod 220 located inside the piston housing 160.

[0117] In FIG. 7 shows an embodiment of an activation system 210b that includes an actuator rod assembly 220 and an activation switch 260. The actuator rod assembly 220 has a generally elongated body with an actuator pin 222 at a first end, an actuator rod 224 at a second end, and a latch movement portion 226 disposed at the intermediate portion. The actuator pin 222 is configured to receive the pressurized chamber 410b within the body 420 and activate the release of the gas contained therein in a second or "open" position.

[0118] The rod 224 of the actuator is configured to abut and follow the contoured surface 262 (FIG. 9) of the switch 260 of the activator. The actuator rod 224 is also preferably shaped so that the cross-sectional profile matches the cross-sectional profile at the top of the bore 169 (as shown in FIG. 8) adjacent to the handle 164 of the piston housing 160. Preferably, the cross-sectional profile is not substantially circular in order to substantially prevent rotation of the actuator rod 220 in the bore 168 of the piston housing 160. The latch moving portion 226 is shaped such that the latch 228 is displaced when the latch 228 is slid along the latch moving portion 226 of the actuator shaft 220 . Thus, the latch 228 has an opening 230 whose cross-sectional shape is similar to that of the latch movement portion 226.

[0119] The actuator switch 260 is configured to bias the actuator rod 220 through portions of the piston housing 160 and through the housing 420 of the pressure chamber 410b to activate the release of the gas contained therein. Thus, the actuator switch 260 may include a cam with a shaped profile 262 along the surface, configured to contact with the rod 224 of the actuator. The actuator switch 260 may also have an opening 264 configured to receive the pin 266 so that the actuator switch 260 can rotate around the pin 266. In the illustrated embodiment, the actuator switch 260 is shown in the first or "closed" position. In this first position, the distance between the pin 266 and the shaped surface 262 contacting the actuator stem can be reduced such that the actuator stem remains in the first or "closed" position.

[0120] When rotated about the pin 266 to the second or “open” position, the distance between the pin 266 and the shaped surface 262 in contact with the actuator stem 224 increases, thereby displacing the actuator stem 220 to the second or “open” position further into the body 420 pressure chambers 410b. As will be described in more detail below with reference to FIG. 10 and 11, movement to the second or "open" position may be configured to release the gas contained in pressurized chamber 410b. The activator switch 260 may preferably be any type of switch that can remain in the first or second position without the user having to maintain the switch in that position. In the illustrated embodiment, a pivot arm is used. Other switches may also be used, such as a screw, latch, spring-loaded pin, or any other switch known in the art.

[0121] In FIG. 8A and 8B illustrate the operation of an activation system 210b, which includes some components of a measurement control system 110b and an activation system 210b. As shown herein, the latch 228 is located within the latch opening 174 so that the latch cannot move towards the front or rear end of the piston housing 160. Thus, when the actuator shaft 220 is moved forward or backward, the latch 228 must follow the profile of the portion 226 to move the latch of the actuator shaft 220. Thus, this provides the advantage of associated movement of the latch 228 in the second position when the actuator switch 260, and thus the actuator rod 220, is in the corresponding second position. In addition, since the movement of the latch 228 is associated with the movement of the other actuator switch 260 and the actuator rod 220, if the latch 228 is not allowed to move to the second position, the actuator switch 260 and the actuator rod 220 will also not be able to move to the second position. It should be noted that, as described above, at the same time in the second or "open" position, the latch 228 may protrude from the piston housing 160, thereby restricting the extension of the piston housing 160, as shown in FIG. 8B

Pressure chamber and first pressure control system

[0122] In FIG. 9 shows an embodiment comprising some components of both the activation system 210b, the pressure chamber 410b of the mixing system 310b, and the first pressure control system 610b of the mixing system 310b. As shown, the pressure chamber 410b may have a housing 420 with an annular slot 422 adjacent the first end of the housing 420. The annular slot 422 may be configured to receive a retaining mechanism 170 located on the piston housing 160. The housing 420 may also have a piston seal 460 located at the second end of the housing 420. The piston seal 460 is configured to provide an airtight seal to form the mixing chamber 510b.

[0123] In FIG. 10 is a sectional view of the pressure chamber 410b and the first pressure control system 610b. The annular slot 422 is located at the first or rear end, and the conical or frustoconical surface 424 is located at the second or front end corresponding to the shape of the piston seal 460. Housing 420 may further be shaped to have an annular lip 426 and an annular slot 428 configured to receive a shoulder 462 of the piston seal 460. This configuration advantageously ensures that the piston seal 460 remains connected to the housing 420 and forms a seal to prevent leakage of any gas contained in the housing 420. The shoulder 462 of the piston seal 460 may fit snugly into the annular slot 428 of the housing 420 to provide improved sealing.

[0124] The interior 430 is substantially surrounded by the body 420 and may be divided into a first separate part 432 and a second separate part 434. The second separate part 434 of the body 420 may contain a third separate part in the form of a structural element, such as a balloon 436. This balloon may contain gases for mixing in the mixing chamber 510b. The provision of gases in a cylinder is advantageous as it facilitates the manufacture of device 10b as it allows the cylinders to be manufactured separately from the other components of pressure chamber 410b. In some embodiments, if the device 10b is reusable, the balloons can be replaced.

[0125] The bladder 436 has a first or rear end in contact with the actuator pin 222 and a sealed second or front end 437. At one end of the bladder 436 is a seal 438 that substantially reduces the leakage of any gas from the first partial portion 432 into the second partial portion. 434. This advantageously reduces the possibility of gas leakage from the opening 440 of the actuator and from the device 10b.

[0126] The housing 420 may also include a bias mechanism 442, such as a spring, that acts on the seal away from the second end of the housing 420. In the illustrated embodiment, the bias mechanism 442 is located in the first separate portion 432. This reduces the likelihood that the balloon 436 will move into the first separate portion 432 and potentially release the gas it contains without being activated by the user. In addition, the bias mechanism 442 may also provide anti-activation so that the user cannot accidentally activate the device. The bias mechanism 442 may be configured to apply sufficient force such that after completion of the first and second phases of operation and return of the actuation switch 160 to the first or “closed” position, the bias mechanism 442 exerts sufficient force to cause the actuator rod 220 to return to its first or the "closed" position, thereby causing the latch 228 to return to its first or "closed" position. Once the latch 228 returns to its first or "closed" position, the extension of the piston housing 160 is no longer restricted and the third phase of operation can begin. If the bias mechanism 442 does not exert sufficient force on the actuator rod 220, the transition to the third phase of operation may be more difficult.

[0127] The body 420 may also have a release mechanism 444, such as a needle or pilot tip, as shown in this embodiment of device 10b, which may be configured to pierce the sealed second end 437 of the gas release cylinder 436 into the first separate portion 432 through the exhaust mechanism 444 via a channel 446 extending axially through the exhaust mechanism 444. Due to the high pressure in the first separate portion 432, the first pressure control system 610b may open allowing gas to escape to the front of the piston seal 460 and into the mixing chamber 510b. In some embodiments, a filter 448 may be placed along the flow path to reduce the chance of foreign materials entering the mixing chamber 510b. In some embodiments, filter 448 may be configured to filter bacteria.

[0128] The piston seal 460 is configured to partially limit the insertion volume of the mixing chamber 510b by providing a seal to the mixing chamber 510b. The piston seal 460 may have a generally cylindrical body with annular projections 464 configured to contact the interior surface of the mixing chamber 510b and a conical or frustoconical surface 466 at the front end. The frustoconical surface 466 may further comprise an opening 468 centered on the cylindrical body, configured to receive components of the first pressure control system 610b. In addition, the housing may also have an opening 470 defined by a bead 462 at a rear end configured to receive the housing 420.

[0129] Continuing with FIG. 10, an embodiment of the first pressure control system 610b is shown in the first or "closed" position. The first pressure control system 610b may include a valve body 620 having multiple openings 622 at one end, a valve stem 624 extending through the valve body 620 with a seat 626 at the rear end configured to contact a bias mechanism 628 and a head 630 at the front end, made with the possibility of contact with the sealing ring 632.

[0130] During operation, the bias mechanism 628 may bias the seat 626 in a rearward direction such that the head 630 is biased against the O-ring 632 and the valve body 620, thereby reducing or preventing gas flow through the valve body 620 and ultimately into mixing chamber 510b. Due to the orientation of the bias mechanism 628, the first pressure control system 610b remains closed until the pressure in the pressure chamber 410b exceeds a threshold value. This threshold value can be set by changing the amount of force required to compress the bias mechanism 628.

[0131] In FIG. 11, an embodiment of the first pressure control system 610b is shown in the "open" position, in which the pressure in the pressure chamber 410b exceeds the pressure in the mixing chamber 510b. In some preferred embodiments, the pressure difference is significant. Due to this pressure difference, sufficient force is applied to the valve components to overcome the action of the bias mechanism 628, thereby allowing the gas to flow out of the valve body 620 into the mixing chamber 510b.

[0132] This configuration of the first pressure control system 610b benefits from the multiple phases of operation of device 10b. During the first and at least part of the second phase of operation, the pressure difference causes the valve to remain open. However, as soon as the pressure difference becomes insufficient to overcome the threshold, the valve remains in the closed position, preventing any additional gas from entering the mixing chamber and potentially violating the calculated pressure/concentration values.

[0133] In FIG. 12 shows an embodiment of a mixing chamber 510b comprising a syringe body 520, a second pressure control system 710b, and various components of the aforementioned systems. The syringe body 520 may be cylindrical and may include an opening 522 at the rear end and a threaded tip 524 at the front end. The syringe body also has a flange 526 configured to engage with the dispenser 120. The mixing chamber 510b may be defined by the inner walls of the syringe body 520 and the plunger seal 460. In addition, on the outer surface of the body of the syringe may contain pointers 528 corresponding to the selected concentration. These indicators 528 may advantageously provide visual confirmation of the selected concentration to the user.

[0134] FIG. 13 shows an embodiment of a second pressure control system 710b comprising a valve body 720 that may include a ball 722, a bias mechanism 724, a seat 726, and a seal mechanism 728. The second pressure control system 710b may also include a second bias mechanism 730 and a pin actuator 732.

[0135] The body 720 of the valve can be displaced in the internal space 734 adjacent to the tip 524 of the body 520 of the syringe. In some embodiments, the second bias mechanism 730 biases the valve body 720 so that the flange 735 of the valve body 720 presses against the inner shoulder 736 of the tip 524. In addition, the bias mechanism 724 can seal and prevent flow through the valve body 720 until sufficient force will not be applied to ball 722 to overcome the biasing force. This may occur when the pressure difference between the mixing chamber 510b and the atmosphere exceeds a threshold value.

[0136] During operation, the second pressure control system 710b is opened during the first and second phases of operation by the increased pressure in the mixing chamber 510b. When the pressure difference becomes insufficient to open the valve body 720, the second phase of operation ends and the user can proceed to the third phase of operation.

[0137] As shown in FIG. 14, the filter 760 is attached to the outlet of the second pressure control system 710b. The filter 760 has a first open end 762 with a flange 764 that is configured to engage threads within the threaded lug 524, a second open end 766, and a filter element 768 disposed therebetween. Thus, the gas can flow in both directions between the first open end 762 and the second open end 766 and be filtered in the process.

[0138] In some embodiments, the inner surface of the first open end 762 tapers towards the second open end 766 such that the shape matches the shape of the valve body 720. When the nozzle 760 is screwed into the threaded tip 524, the nozzle 760 engages with the valve body 720 and biases the valve body 720 against the biasing force of the second bias mechanism 730 towards the rear end of the syringe body 520. This causes the ball 722 to contact the pin actuator 732, thereby causing the ball to move away from the inside surface of the valve body 720, which allows gas to pass through the valve body 720 in any direction. This configuration allows the mixing chamber 510b to be further expanded at atmospheric pressure and filter the air sucked into the mixing chamber 510b. Thus, in this position it is possible to carry out the third phase of work. After completion of the third phase of operation, the filter 760 can be removed. Through the force of the second bias mechanism 730, the valve body 720 can be displaced away from the pin actuator 732 such that the valve body 720 remains closed until the user chooses to use therapeutic gas in the mixing chamber 510, for example, by attaching an injection needle to administering therapeutic gas to the patient.

Embodiment of measurement control system and activation system

[0139] FIG. 15-31 depict further embodiments of the device's measurement management system components.

[0140] In FIG. 15A and 15B show an embodiment of a dosing dial 820 that can be configured to allow the user of the device to select the fluid concentration for the volume to be injected. Like other embodiments, the dial gauge 820 may include two components, such as a dial gauge housing 822 and a dial cap 824 that can be detachably attached to the dial gauge housing 822.

[0141] Continuing with FIG. 15A and FIG. 15B, the dial gauge housing 822 may have a generally cylindrical member 830 with a flange 832 located at the top of the dial gauge housing 822. The dial gauge housing 822 may include a channel 834 located substantially centrally on the cylindrical member 830 and extending through the entire dial gauge housing 822. In some embodiments, such as shown in FIG. 15A, the generally cylindrical member 830 may include additional surface components, such as an enlarged diameter portion 831, that can potentially be adapted to the device into which it is inserted.

[0142] As is the case with other embodiments of dial metering controls or similar metering mechanisms, this embodiment may also include metering indicators 836 located on the surface of the metering dial housing 820. In this illustrated embodiment, the dosage indicators 836 are located on the upper surface of the flange 832, although any other visible location may be used, such as, for example, part of the perimeter of the flange 832. In the illustrated embodiment, the dosage indicators 836 show a range of numbers: 18, 19, 20, 21 and 22 corresponding to the concentrations of sulfur hexafluoride (SF ₆ ) that can be formed in the injection volume of the assembly.

[0143] As with other embodiments of dial gauges and other metering mechanisms, the dial gauge housing 822 may have slots 838, rails 840, and adjustable stops corresponding to the metering indicators 836.

[0144] The operation of the adjustable stops of the illustrated embodiment of the dial gauge 820 may be similar to that of other embodiments of the dial dial and dispense mechanisms. The adjustable stops may be configured to interact with components contained in the plunger body 860, such as a latch 928 or similar projecting structure, to control the expansion of the volume chamber during at least some phases of operation. In some embodiments, adjustable stops may accomplish this task by limiting the rearward movement of piston housing 860 during various phases. Thus, the adjustable stops travel different distances depending on the concentration to which the stop corresponds.

[0145] In FIG. 16 shows an embodiment of a piston body 860 that may comprise a tubular frame 862 as a whole, a handle 864 at one end of the piston body 860, a switch member 866 located therebetween, and a passage 868 that is centrally located on the tubular frame 862 and that may extend throughout the length of the piston housing 860, or which may extend at least a portion of the length of the tubular frame 862. The tubular frame 862 may be slidable and pivotable in the channel of the dial gauge.

[0146] Continuing with FIG. 16, the roll cage 862 may include a latch opening 874 to allow a latch 928 located on the activation rod 920 and contained in the channel 868 to protrude outwardly from the roll cage 862. As shown in the illustrated embodiment, the latch opening 874 may have a slightly higher center. the topmost portion of the guard 872. In other embodiments, the latch opening 874 may also be located at various positions along the roll cage 862 and may include more than one latch opening if multiple latches are used.

[0147] As described in more detail below, in the first, "initial" or "pre-activation" position, the latch 928 may be sized so that it does not extend beyond the guard 872 and thus does not touch the adjustable stop or the like. When in the second or “open” position, the latch 928 may protrude outward from the roll cage 862 beyond the guard 872 so that the latch 928 may contact adjustable stops or the like, thereby preventing or greatly reducing the likelihood of further extension of the piston housing 860 when the latch is in the second position.

[0148] Continuing with FIG. 16, 25a and 25b, the actuator switch 960 may be configured to bias the actuator rod 920 through the piston housing 860 towards the first housing member 1020 to activate the mechanism to release the gas contained therein. Thus, the actuator switch 960, like the actuator switch of other embodiments, may be a shaped cam 962 positioned along the surface and configured to contact the actuator housing 922. The actuator switch 960 may further comprise a hole 964 configured to receive a pin so that the actuator switch 960 can rotate around the pin. One skilled in the art will appreciate that the activation switch 960 can preferably be any type of switch that can remain in the first, second, or multiple positions without the user having to maintain the switch in that position. In the illustrated embodiment, a pivot arm is used. Other switches may also be used, such as a screw, latch, spring-loaded pin, or any other switch known in the art.

[0149] In FIG. 18, the activator switch 960 is shown in the first, "initial" or "pre-activation" position. For example, this may be the position before the first phase of work. In this first position, the distance between the pin 966 and the shaped surface 962 in contact with the actuator housing 922 may be a first distance, whereby the actuator housing 922 is located at a first distance from the end of the tubular frame 862 of the piston housing 860.

[0150] As shown in FIG. 19, in some embodiments, the actuator switch 960 may be rotated to a more vertically oriented position, a second or "open" position, in which the distance from the pin 966 to the shaped surface 962 in contact with the actuator housing 922 may be a second distance, due to whereby the body 922 of the actuator is located at a second distance from the end of the tubular frame 862 of the body 860 of the piston. This may correspond to the position of the activation switch 960 during the first and second phases of operation. In some embodiments, the second distance may be greater than the first distance. As will be described in more detail with reference to FIG. 25-27, this can cause the actuator housing 922 to move in the direction of the first pressure chamber housing member 1020. This displacement may activate the release of the fluid or gas contained in the pressure chamber.

[0151] As shown in FIG. 20, in some embodiments, the activation switch 960 may also be rotated to a more horizontally oriented position, a third or “closed” position, in which the distance from the pin 966 to the shaped surface 962 contacting the actuator housing 922 may be a third of the distance whereby the body 922 of the actuator is located at a third distance from the end of the tubular frame 862 of the body 860 of the piston. This may correspond to the third phase of operation and/or the final phase before the injection of the injected volume into the patient. This third distance may be less than or equal to the first and/or second distances. In some embodiments, rotation to the third position may cause the actuator housing 922 to move away from the first pressure chamber housing member 1020 so that no fluid or gas is released from the pressure chamber.

[0152] Optionally, a locking mechanism may be provided to control and restrict movement of the activation switch 960.

[0153] FIG. 21-23 show the operation of an embodiment of an activation system. As shown in the illustrated embodiment and like other embodiments, the latch 928 may be contained within the latch opening 874 such that the latch cannot move towards the front or rear end of the piston housing 860. In such an embodiment, when the actuator shaft 920 is moved forward or backward, the latch 928 is configured to follow the profile of the latch portion 926 of the actuator shaft 920.

[0154] In FIG. 21 shows the embodiment in the first, "initial" or "pre-activation" position. As shown here, the latch 928 can be positioned to protrude out of the piston housing 860 sufficiently so that when pulled back, the latch 928 contacts the adjustable stop located on the dial gauge housing 922 and prevents any further extension. In other embodiments, when the latch 928 is in the first position, it may be configured not to protrude out of the housing 860 to prevent such protrusion. When moved to the second or "open" position, as shown in FIG. 22, the latch 928 may protrude outwardly from the piston housing 860 sufficiently so that the latch 928 may contact the adjustable stop or similar structure located on the dosage dial 820, thereby preventing any further rearward movement. When rotated to the third or "closed" position, as shown in FIG. 23, the latch 928 can be sufficiently retracted into the latch opening 874 such that the latch 928 no longer contacts the adjustable stop or the like located on the dial 820, thereby allowing the piston body 860 to extend further rearward.

[0155] Continuing with FIG. 21-23, a ratchet 886, such as a pawl, may be attached to the piston housing 860. The ratchet member 886 may be articulated and may be configured such that the ratchet member 886 is movably deformable and provides resistance during deformation. The ratchet 886 may correspond to features located on the plunger body dial 820, such as notches 842, FIG. 15b to facilitate correct orientation with respect to the selected concentration. In order to allow deformation inwards of the ratchet element 886, the actuator housing 924 may include a recess or notch 980. This recess 980 may be configured to allow deformation inward of the ratchet element 886 only in the first and third positions, while deformation inwards of the ratchet element 886 is prevented when it is in the second position. This reduces the likelihood that the piston housing 860 may rotate during operation of the device.

Embodiment of the pressure chamber

[0156] In FIG. 24-25B show an embodiment of a pressure chamber along with activation system components. As shown, the pressure chamber may have a two-piece housing with a first housing element 1020 and a second housing element 1022 that are movable relative to each other. As shown in the illustrated embodiment, the two elements 1020, 1022 may be generally cylindrical so that some or all of the two elements 1020, 1022 may fit into the bore 868 of the piston housing 860. In some embodiments, the two elements 1020, 1022 can be detached from each other to allow free displacement of the two elements 1020, 1022. In other embodiments, the two-piece housing can be attached while still allowing the elements 1020 to be displaced 1022 relative to each other. This attachment can be used to increase the stability of the two elements 1020, 1022.

[0157] As shown in the illustrated embodiment, and similar to other pressure chamber embodiments, an annular slot 1024 may be located on the second housing element 1022. In the illustrated embodiment, the annular slot 1024 is located at the end opposite the first housing element 1020, however, there may be other possible locations are selected. Annular slot 1024 may be sized and configured to receive retaining wings 870, FIG. 25A of the piston housing 860, allowing the second housing element 1022 to be lockably attached to the piston housing 860. To facilitate insertion of the second housing element 1022 into the bore 868 of the piston housing 860, the insertion end may be slightly tapered. In some embodiments, the second housing element 1022 may be detachably attached to the piston housing 860 to allow certain parts contained therein to be replaced. For example, in some embodiments, a two-piece housing may contain a storage element 1030 or a balloon. The two-piece body may also have a plunger end 1060 with a plunger seal 1061, such as a rubber o-ring, configured to seal against the syringe body 1120 and form a seal to define a chamber containing the volume to be injected, which chamber can potentially perform mixing chamber functions. Other types of sealing elements may be used to form such a seal around piston end 1060.

[0158] FIG. 25A and 25B are sectional views of the embodiment shown in FIG. 24 when the device is in the first, "initial" or "pre-activation" position. As shown more clearly in FIG. 25B, in a first position, a stem bias member 924, such as a coil spring, may contact both the actuator housing 922 and the first housing member 1020; however, the actuator housing 922 may not be in direct contact with the first housing element 1020. In the first position, the rod displacement member 924 may apply a forward force to the first housing member 1020 and a rearward force to the actuator housing 922 such that the actuator housing 922 remains in contact with the activation switch 960. In this position, the forward force acting on the first housing element 1020 may cause the first housing element 1020 to exert force on the storage element 1030 contained therein as the first housing element 1020 attempts to move toward the second housing element 1022. Preferably, in the first position, the force applied by the first housing element 1020 to the storage element 1030 will not be sufficient to displace the storage element 1030 towards the second housing element 1022 due to the mechanisms contained in the storage element 1030 (as will be discussed in more detail below in FIG. 28 -29). Thus, while in the first position, any gas or fluid contained in the storage element 1030 will remain inside the storage element 1030.

[0159] FIG. 26A and 26B are sectional views of the embodiment shown in FIG. 24 when the device is in the second or "open" position. As shown more clearly in FIG. 26B, while in the second position, both the actuator housing 922 and the stem displacement member 924 may directly contact the first housing member 1020. Due to this direct contact, more force may be applied to the first housing element 1020, whereby the first housing element 1020 may be displaced in the forward direction, thereby causing the storage element 1030 to be displaced in the forward direction. This forward displacement of the storage element 1030 may then activate the release of gas from the storage element 1030. In other embodiments, the actuator housing 922 does not need to be in direct contact with the first housing element 1020 because, in such embodiments, the increase in force applied by the rod displacement element 924 due to the compression of the rod displacement element 924 may be sufficient to cause the first element to be displaced. 1020 housing in the forward direction to cause the activation of the release of gas from the element 1030 storage.

[0160] In FIG. 27A and 27B are sectional views of the second embodiment shown in FIG. 24 when the device is in the third or "closed" position. As shown in FIG. 27B, while in the third position, the actuator housing 922 is in contact with the first housing member 1020. In addition, in some embodiments, due to the reduced distance between the pin 966 and the shaped surface 962, the force exerted by the stem displacement member 924 on the actuator housing 922 in the rearward direction may cause the actuator housing 922 to move toward the shaped surface 962 such that body 922 of the actuator remains in contact with the switch 960 activation. This extension of the rod bias element 924 results in a decrease in the force applied by the rod bias element 924 to the first housing element 1020. As a result of this reduced force, and as a result of other mechanisms located within the storage element 1030 or balloon, the storage element 1030 can be returned to the closed state, thereby preventing any additional gas from being released into the injection volume holding chamber, which may also serve as a mixing chamber.

[0161] In FIG. 28 is a sectional view of an embodiment of a pressure chamber. The first and second housing elements 1020, 1022 comprise a storage element 1030 or a container, such as a microcylinder, that contains a fluid such as a gas. In some embodiments, the implementation of the second element 1022 has at the end opposite the first element 1020, a conical surface or a surface in the form of a truncated cone, forming the end 1060 of the piston. In some embodiments, the implementation of the second element 1022 and the end 1060 of the piston form a single unit. The piston end 1060 may have an annular slot configured to receive a piston seal 1061, such as a rubber o-ring, to form an injection volume chamber, which may also serve as a mixing chamber.

[0162] The first body element 1020 may include a recessed portion 1026 or a recessed portion configured to contact and receive the first end of the storage element 1030. The shape of the recessed portion 1026 should preferably match the shape of the first end of the storage element 1030. In other embodiments, the first housing element 1020 may not include a recessed portion 1026. The second housing element 1022 may include an internal space 1028 sized and configured to receive the second end of the storage element 1030. In some embodiments, the internal space 1028 may include a housing seal 1029 in contact with the second end of the storage element 1030. In some embodiments, the body seal 1029 creates a seal sufficient to minimize or eliminate backflow of gas through the interior 1028. In some embodiments, the interior 1028 may also provide a generally tight fit around the storage element 1030 to ensure that that the storage element 1030 as a whole only moves forward and backward. This advantageously reduces the chance of seal failure between the second end of the storage element 1030 and the housing seal 1029.

[0163] Continuing with FIG. 28, a storage element 1030, such as the illustrated balloon or microcylinder, may include a body 1040 and a head 1042. As shown in the illustrated embodiment, the body 1040 may have a generally cylindrical shape with a hemispherical first end. The body portion 1040 together with the head 1042 may form an internal volume 1041 to contain a fluid such as a gas, in gaseous or liquid form, or a combination thereof, at a first pressure and concentration, which may be different from atmospheric gas. For example, such gases may include, but are not limited to, expanding gases, ophthalmic gases such as SF ₆ , C ₃ F ₈ , C ₂ F ₆ or similar gases, propellant gases such as CO ₂ , refrigerant gases such as N ₂ O, and other gases of various types. The size of the internal space 1041 can be chosen such that the volume can contain a single or single dose. Other shapes may be chosen for body 1040.

[0164] Head 1042 may have a generally tubular shape with an outer diameter matching the inner diameter of body portion 1040. Head 1042 may have an internal bore and flange 1044. As shown in the illustrated embodiment, the first end of head 1042 may have a hole with a diameter corresponding to the diameter of the channel, and the second end of the head may have a hole 1046 with a diameter that is less than the diameter of the channel. In some embodiments, body 1040 and head 1042 may be separate components that are attached later. This has the potential to be advantageous for ensuring that the internal components of the head 1042 are assembled prior to assembly. Once all components are assembled within the head 1042, the head 1042 may be placed within the body portion 1040 and secured using devices and mechanisms such as adhesives, welding, and the like. In some embodiments, such as shown in FIG. 28, flange 1044 may abut against body portion 1040 and be glued or welded along this surface. In other embodiments, body 1040 and head 1042 may be integral.

[0165] The head 1042 may include a storage element pressure control system, which may form part of the first pressure control system, and which may take the form of an internal valve mechanism within the channel. The internal valve mechanism may include a retaining ring 1048, a valve seat 1050, an internal bias member or mechanism 1052 such as a spring, a valve piston 1054, and a piston seal 1056. The retaining ring 1048 may be placed within an annular slot 1058 located on the head 1042. The retaining ring 1048 may be made of a resilient material such that the retaining ring may be deformed before fitting into the slot 1058. A valve seat 1050 may be placed between the retaining ring 1048 and the second end of the head 1042. In some embodiments, the valve seat 1050 may be a ring having an outside diameter approximately equal to the inside diameter of the head 1042.

[0166] The valve piston 1054 may have a generally cylindrical shape and be located between the seat 1050 and the second end of the head 1042. The outer diameter of the valve piston 1054 may be chosen to be approximately equal to the inner diameter of the head 1042. As shown in the illustrated embodiment, the valve piston may include an annular a slot configured to receive a piston seal 1056, fluid passages 1055 or channels located around the perimeter of the piston, and a ledge 1057. The fluid passages 1055 may be configured to allow fluid to pass between the valve piston 1054 and the head 1042. the illustrated embodiment has a total of four fluid passages; however, fewer or more passes may be used. In some embodiments, the projection 1057 may be a cylindrical element having a smaller diameter that matches the diameter of the opening 1046. The projection 1057 may be configured to enter the opening 1046. In some embodiments, the projection 1057 may be flush with the end surface of the head 1042. In other embodiments, the implementation of the protrusion 1057 may be recessed into the hole or extend beyond the end surface. A bias mechanism 1052 may be placed between the seat 1050 and the piston 1054 to force the valve piston 1054 in a forward direction to form a seal between the piston seal 1056 and the head 1042. In other embodiments, other types of valve designs may be used, such as a ball valve, poppet valve, or any other valve mentioned herein or known in the art.

[0167] In some embodiments, the internal bias mechanism 1052 may be configured such that when the activation switch is in the first or "pre-activation" position, the internal valve mechanism will not open as a result of forces applied to it, such as force applied to storage element 1030 through the first housing element 1020 caused by the rod displacement mechanism 924. In some embodiments, the internal bias mechanism 1052 may be configured such that when the activation switch is in the second or "open" position, the internal valve mechanism opens as a result of forces applied thereto. In some embodiments, the internal bias mechanism 1052 may be configured such that when the activation switch is in the third or "closed" position, the internal valve mechanism will not open as a result of forces applied thereto, such as the force applied to the storage element 1030 through the first housing element 1020 caused by the rod displacement mechanism 924.

[0168] In some embodiments, storage element 1030 may include other structures, such as filters built into portions of storage element 1030, such as head 1042. Storage element 1030 may include membranes or other sealing structures placed over head 1042 and over opening 1046 to provide additional sealing that can advantageously extend the storage life of the storage element 1030. The membrane or sealing structure may be pierced by a projecting element such as a 1059 pin or any other similar release mechanism. In some embodiments, the release mechanism may be a porous material, such as known as a "frit". The storage element 1030 may also contain additional valve elements that can serve as a safety valve to reduce the likelihood of rupture if the pressure in the storage element 1030 exceeds certain operating limits. The storage element 1030 can also be configured to break in a controlled manner to reduce the chance of a fatal failure.

[0169] In some embodiments, the storage element 1030 and internal components, such as the internal valve, are made from materials that are both small and lightweight. The material can also be flexible. In some embodiments, the materials and dimensions of the storage element 1030 may be chosen such that the storage element 1030 prevents gas from diffusing through the walls of the storage element 1030. This may provide the advantage of increasing the shelf life of the storage element 1030 when it contains gas. In some embodiments, the length of the storage element 1030 from the rearmost end of the housing 1040 to the most forward end of the head 1042 may range from about 15 mm to about 65 mm, from about 20 mm to about 45 mm, and from about 25 mm to about 35 mm. e.g. 29 mm. In some embodiments, the external diameter of housing 1040 may range from about 4 mm to about 25 mm, from about 6 mm to about 20 mm, and from about 8 mm to about 15 mm, such as 9.5 mm. In some embodiments, the outside diameter of head 1042, excluding the flange portion, may be from about 2 mm to about 20 mm, from about 4 mm to about 15 mm, and from about 6 mm to about 10 mm, such as 7.5 mm.

[0170] Continuing with FIG. 28, a pin 1059, which may serve as a release mechanism, may be located within the channel 1062. The release mechanism 1059 may be substantially centered over the boss 1057 of the valve piston 1054 and have a diameter that matches that of the orifice 1046 and may form through passages (not shown). ). As shown in FIG. 29, during operation, when the storage element 1030 is displaced forward towards the release mechanism 1059, the release mechanism 1059 remains stationary, whereby the release mechanism 1059 can cause the valve piston 1056 to disengage from the head 1042, thereby allowing fluid flow from the element 1030. storage through passages 1055 and release mechanism 1059 and through passage 1062 where it may eventually flow into an injection volume chamber, such as a mixing chamber. In some embodiments, the release mechanism 1059 may comprise internal or external channels, or may be made of a porous material such that the release mechanism 1059 itself serves as a pre-filter mechanism for the fluid flowing through the channel 1062. In some embodiments, filters may be added between outlet mechanism 1059 and channel end 1062 or any other location to filter materials.

[0171] In FIG. 30-32 shows another version of the surgical kit 2c containing a container 4c with a device 10c for mixing gases. The gas mixing device 10c may comprise the same or similar components described above with reference to the gas mixing devices 10, 10a and 10b, except as noted below.

[0172] The mixing device 10c may include an injection volume chamber, such as a mixing chamber, which may include a syringe body 1120, a syringe pressure control system that may form part of a second pressure control system, and various components of the above systems. The body 1120 of the syringe may have a cylindrical body and spout 1122 at the front end.

[0173] In some embodiments, the implementation of the threaded tip 1124, which may contain several components of the pressure control system, can be detachably attached to the nose 1122 of the body 1120 of the syringe. This may advantageously facilitate device assembly by allowing the pressure control system to be assembled within the smaller tip 1124 prior to being included in the syringe body 1120. The tip 1124 may be attached to the spout 1122 using a variety of attachment devices and means such as screws, adhesives, interlocks, welding, and the like. The injection volume chamber may be formed by the inner walls of the syringe body 1120 and the plunger seal 1061. In addition, as in other syringe embodiments, the syringe body 1120 may also include indicators along its outer surface corresponding to the selected concentration, and a flange at the rear end of the body 1120, configured to be attached to a dosage dial. Optionally, the surgical kit 2c may include a flow restrictor 1300 connected to the outlet 761c of the filter device 760c.

[0174] Continuing with FIG. 30-32 illustrating an embodiment of a syringe pressure control system comprising a valve body 1220, a valve end 1222, a valve piston 1224, a piston seal 1226, a piston displacement element or mechanism 1228, a valve displacement element or mechanism 1230, and a valve end seal 1232. Like other embodiments of the pressure control system, the valve body 1220 and valve end 1222 can be slidably displaced within the threaded tip 1124.

[0175] In the first position, such as shown in FIG. 32, valve end 1222 may abut against shoulder 1234 of threaded lug 1124 due to the force exerted by valve bias member 1230 against valve body 1220 and valve end 1222 in the forward direction. In the first position, the valve piston 1224 and the valve seal 1226 may form a seal and restrict or prevent fluid from passing through the valve body 1220. However, when the pressure in the injection volume chamber is increased beyond a threshold to overcome the biasing force exerted by the piston biasing element 1228, the valve piston 1224 may be displaced forward against the force applied by the piston biasing element 1228 and fluid may pass through the valve body 1220 and end 1222 valves to atmosphere. Once the pressure is reduced to a threshold value, the balance of forces allows the valve piston 1224 and the valve seal 1226 to seal against the valve body 1220 again.

[0176] In the second position, the valve body 1220 and the valve end 1222 can be displaced in a rearward direction relative to the valve displacement element 1230. For example, this can be achieved by applying force in a rearward direction to the end 1222 of the valve. In the second position, contact between the valve plunger 1224 and the internal protrusion 1126 of the syringe body 1120 may cause the valve plunger 1224 to move rearward relative to the valve body 1220 and valve end 1222 such that the valve plunger 1224 no longer seals against the valve body 1220. In some embodiments, this could allow fluid to pass in and out of the chamber for the volume to be injected. In some embodiments, the pressure control system can be forced into the second position when the inline filter 760c is screwed onto the threaded lug 1124. Other types of devices, such as stopcocks, valves, tubes, etc., may also be attached to the threaded lug. 1124.

[0177] As shown in FIG. 32-35, flow restrictor 1300c may be in the form of a cap configured to engage with outlet 761c of filter device 760c. For example, flow restrictor 1300c may include a threaded end 1032 configured to engage threads on an inner surface of outlet 761c. In addition, the flow restrictor 1300c may include optional finger grips 1304 configured to be easily gripped by the fingers to facilitate removal of the flow restrictor 1300c while wearing surgical gloves.

[0178] The flow restrictor may also include a flow restriction opening 1306. In some embodiments, the minimum diameter of opening 1306 may be less than the smallest diameter of outlet 1308 of outlet 761c (FIG. 30). Thus, the minimum cross-sectional area of outlet 1306 may be less than the minimum cross-sectional area of outlet 1308. Thus, as described above with reference to FIG. 1A and flow restrictor 1300c. Let us continue to consider Fig. 30, an operating mixing device 10c may be packaged in a container 4c to form a surgical kit 2c. Like the other mixing devices 10, 10a, 10, and 10b, the mixing device 10c may be packaged in a container 4c with a pre-attached filter device 760c in a sterilized state, and optionally may also include a flow restrictor 1300.

[0179] In use, the practitioner or other user may remove the mixing device 10c from the package 4c with the filter 760c pre-attached. The user can then supply the therapy gas and/or component thereof to the mixing chamber of device 10c, which moves piston 1061 away from filter device 760c (as shown in FIG. 30) until piston 1061 is moved to the desired position. volume of therapeutic gas, which will provide the desired concentration of mixed gas. After piston 1061 has been moved to the desired position, excess therapy gas may be released through filter device 760c. Thus, since the filter device 760c is pre-attached to the mixing device 10c, unfiltered atmospheric air will never be in any open volumes between the filter element 763 of the filter device 760c and the piston 1061. Thus, during the release of therapeutic gas through this filter device 760c, no contaminants, foreign matter, or unwanted gases will be trapped on the upstream side of the filter element 763.

[0180] After placing the desired volume of therapeutic gas or its component in the mixing chamber, the user can manually move the piston 1061 away from the filter device 760c and thereby draw atmospheric air through the outlet 761c of the filter device 760c, through the filter element 763 into the mixing camera. Thus, the filter element 763 can filter out any particulate matter, foreign matter, or unwanted gases and prevent them from entering the mixing chamber. Once the mixing chamber has been expanded to the desired volume and the desired concentration of therapeutic mixture is formed, the filter device 760c can be removed and an additional delivery device can be connected in its place. For example, a hypodermic needle may be attached in place of the therapeutic gas delivery filter device 760c.

[0181] As noted above, the mixing device 10c may optionally be packaged in a container 4c with a flow restrictor 1300c pre-attached. The pre-attached flow restrictor 1300c provides the optional additional benefit of providing additional back pressure during venting of excess gas, thus allowing piston 1061 to be fully pressed against any restrictor to restrict a given volume of therapeutic gas or therapeutic gas component within the syringe body 1120 .

[0182] In some embodiments, the pressure chamber may be external to the device. In such embodiments, the pressure chamber may be a container or other container containing gas in liquid or gaseous form (or a combination of these forms). In some embodiments, the implementation of the container may be attached to the threaded tip using a tube or other mechanisms. The connection between the threaded lug and the tube may force open the pressure control system located on the device, thereby allowing the gas from the container to flow into the chamber. In some embodiments, the implementation of the introduction of gas from the tank can be performed during the first phase of operation. Thus, the gas from the container can fill the device with gas until the device reaches a predetermined first volume. In some embodiments, the container may have a regulator to allow the device to be filled with a controlled pressure gas. The connection can then be removed from the threaded end, allowing the valve to function properly. In some embodiments, because the gas may be at a higher pressure than atmospheric air and may exceed the threshold for the pressure control system, the gas may be vented or expelled from the system until the device reaches a predetermined pressure. Once the device has reached the desired pressure, the remaining phases of operation can be completed like the phases in the embodiments described above.

[0183] The above description relates to an apparatus and method for mixing and/or introducing gases having certain features, aspects and advantages according to the present invention. Various changes and modifications can also be made to the device and method of mixing gases described above without deviating from the essence and scope of the invention. Thus, for example, those skilled in the art will understand that the invention may be embodied or carried out in such a way as to achieve or optimize one advantage or group of advantages as described herein, without the need to achieve other objectives or advantages that may be considered. or suggested in this document. In addition, although a number of variations of the invention have been shown and described in detail, other modifications and uses that are within the scope of this invention will be readily apparent to those skilled in the art based on this description. It is contemplated that various combinations or subcombinations of specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments may be combined or substituted for each other to provide various modes of the disclosed gas mixing device.

Claims (44)

1. A manual gas injector assembly for delivering therapeutic gas to a patient, comprising: syringe body with outlet pipe; a plunger slidably disposed within the syringe body and, together with the syringe body, defines a first chamber within the syringe body; a second chamber located in at least one of the syringe body and plunger, the second chamber comprising: an internal volume containing at least the first fluid at a concentration different from the concentration in atmospheric air, and at a pressure greater than the pressure of the ambient atmospheric air; an opening at the first end of the second chamber; and a valve mechanism disposed adjacent the first end, the valve mechanism being configured to seal the opening; a channel and opening between the second chamber and the first chamber; an activation system operably coupled to the second chamber, the activation system configured to release the first fluid from the second chamber into the first chamber through the channel; an adjustable volume limiter configured to limit piston movement to multiple user-selectable positions corresponding to multiple volumes of the first chamber; a filter having a first end connected to the outlet of the syringe body, a second end with a filter opening, and a filter element located between the first end and the second end; and a flow restrictor connected to the filter opening, and having a restrictor opening that is smaller than the filter opening, and configured to restrict the flow of fluid from the first chamber through the filter opening so that the first fluid from the second chamber moves from the second chamber through a valve mechanism located adjacent the first end of the second chamber, through the first chamber, through the first end of the filter, through the filter, through the second end of the filter with the filter opening, and then through the flow restrictor opening outward from the manual gas injector assembly; moreover, the flow restrictor is configured to create a backpressure against the flow of fluid from the first chamber to expand the first chamber to a desired volume corresponding to a user-selectable position of the volume restrictor. 2. The device according to claim 1, characterized in that the filter is detachably connected to the body of the syringe. 3. The device according to claim 1, characterized in that the flow restrictor comprises a lumen, the first end of which is configured to receive fluid from the filter opening, and the second end contains the restrictor opening, the lumen narrowing between the first end and the second end. 4. The device according to claim. 1, characterized in that the flow restrictor is a cap made with the possibility of interaction with detachment with the release of the filter. 5. Manual gas injection device assembly, comprising: syringe body with outlet pipe; a plunger slidably disposed within the syringe body and, together with the syringe body, defines a first chamber within the syringe body; an adjustable volume limiter configured to limit piston movement to multiple user-selectable positions corresponding to multiple chamber volumes; a filter, the first end of which is connected to the outlet of the syringe, and the second end is connected to the filter opening; and a flow restrictor connected to the filter opening, and having a restrictor opening that is smaller than the filter opening, and configured to restrict the flow of fluid from the chamber through the filter opening so that the fluid leaving the syringe moves through the first end of the filter, through the filter, through the second end of the filter with the filter opening and then through the flow restrictor opening to the outside of the manual gas injector assembly; moreover, the flow restrictor is configured to create a backpressure against the flow of fluid from the chamber to expand the chamber to a desired volume corresponding to a user-selectable position of the volume restrictor. 6. The device according to claim. 5, characterized in that it further comprises a filling mechanism configured to direct the fluid into the chamber. 7. The device according to claim 5, characterized in that the filter is detachably connected to the body of the syringe. 8. The device according to claim 5, characterized in that the flow restrictor comprises a lumen, the first end of which is configured to receive fluid from the filter opening, and the second end contains the restrictor opening, the lumen narrowing from a larger size at the first end to a smaller size at second end. 9. The device according to claim. 5, characterized in that it further comprises a valve mechanism having a first position and a second position, and the valve mechanism is configured to prevent the flow of fluid from the chamber when in the first position and to pass the flow of fluid from the chamber when in in the second position. 10. The device according to claim. 5, characterized in that the flow restrictor is a cap made with the possibility of interaction with detachment with the release of the filter. 11. Manual device for the introduction of gas assembly, containing: a syringe body comprising an end wall and an outlet connected to the end wall; a plunger slidably disposed within the syringe body and, together with the syringe body, delimiting a first chamber within the syringe body and between the plunger and the end wall, the piston being positioned on the end wall of the syringe body such that the first chamber has a volume limited by the movement of the plunger; a second chamber, wherein the second chamber contains an internal volume containing at least the first fluid at a concentration different from the concentration in atmospheric air and at a pressure greater than the pressure of the ambient atmospheric air, the second chamber being fluidly connected to the first chamber to ensure release the first fluid from the second chamber to the first chamber; a filter, the first end of which is connected to the outlet of the syringe, and the second end is connected to the filter opening; and a flow restrictor connected to the filter opening and configured to restrict the flow of the first fluid from the first chamber through the filter opening, wherein the flow restrictor comprises a restrictor opening that is smaller than the filter opening, wherein the first fluid leaving the syringe moves through the first end of the filter, through the filter, through the second end of the filter with the filter opening, and then through the flow restrictor opening to the outside of the manual gas injector assembly; wherein the flow restrictor is configured to create back pressure against the flow of the first fluid from the chamber to expand the first chamber to a desired volume corresponding to a user selectable volume restrictor position of the manual gas injector assembly. 12. The apparatus of claim. 11, further comprising an adjustable volume limiter configured to limit the movement of the piston to several user-selectable positions corresponding to several volumes of the first chamber. 13. The apparatus of claim. 11, further comprising a filling mechanism configured to direct the first fluid into the first chamber. 14. The device according to claim 11, characterized in that the filter is detachably connected to the body of the syringe. 15. The device according to claim 11, characterized in that the flow restrictor comprises a lumen, the first end of which is configured to receive fluid from the filter opening, and the second end contains the restrictor opening, the lumen narrowing between the first end and the second end. 16. The device according to claim. 11, characterized in that it further comprises a valve mechanism configured to move between the first position and the second position, and the valve mechanism is configured to obstruct the flow of fluid from the first chamber when in the first position and pass the flow of fluid environment from the first chamber while in the second position. 17. The device according to claim 16, characterized in that the valve mechanism includes a valve body, a piston, a seal, a valve bias element and an internal protruding element. 18. The device according to claim 16, characterized in that the filter is detachably connected to the syringe body, and the filter is configured to interact with the valve mechanism when it is connected to the syringe body to transfer the valve mechanism from the first configuration to the second configuration. 19. The apparatus of claim 13, wherein the second chamber comprises an opening at the first end and an internal valve mechanism located adjacent the first end, the internal valve mechanism being configured to seal the opening. 20. The apparatus of claim 19, wherein the internal valve mechanism comprises a piston, a seal, and a bias element, wherein the internal valve mechanism is configured to seal the opening at least until the device assembly is activated.

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